CLASS II Device recall · Reported 24 Jan 2018 · FDA Enforcement Report
Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw, Length recalled
Spineart is recalling Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw, Length, distributed in California. The recall was initiated on 27 Nov 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0337-2018
- FDA event ID
- 78640
- Recalling firm
- Spineart, Geneva 15, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Nov 2017
- FDA classified
- 12 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Spinal Implants
Timeline
| 27 Nov 2017 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +46 days |
| 24 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF TRY-PS-40 14-S, Qty 2 TRYPTIK(R) 2C-Plate Anterior Cervical Plate System is intended to be used for temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion in patients with instability caused by the following degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e., scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
Where it was distributed
US Distribution to the state of : CA
Questions about this recall
Is Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw, Length recalled?
Yes. Spineart recalled Tryptik(r) 2 C-plate Self-tapping Polyaxial Screw, Length on 27 Nov 2017. The recall is Class II and its status is Terminated. Recall number Z-0337-2018.
Why was it recalled?
Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the sketch/drawing of a self-drilling screw.
Which lots are affected?
batch: 3-5934
Where was it sold?
US Distribution to the state of : CA
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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